Bjelović, Miloš
Harsányi, László
Altorjay, Áron
Kincses, Zsolt
Forsell, Peter
Gunjić, Dragan
Veselinović, Milan
Babič, Tamara
Lukovich, Péter
Kakucs, Timea
Kathy, Sándor
,
Article History
Received: 26 February 2020
Accepted: 9 June 2020
First Online: 20 July 2020
Ethics approval and consent to participate
: Informed written consent was obtained from all individual participants included in the study. The study was reviewed by:<b><i>Ethics Committee: Hungary</i></b>The Medical Research Council (MRC), Scientific and Research Ethics Committee (SREC)<sup>A</sup>, Alkotmány u. 25, H-1054 Budapest, Hungary.<sup>A</sup> An independent Central Ethics Committee (CEC) responsible for the independent review and approval for all medical device trials in Hungary. Trial approval reference number: 048734/2016/OTIG, issued by the Hungary Regulatory Authority the National Institute of Pharmacy and Nutrition.<b><i>Ethics Committee: Serbia.</i></b>Ethics Committee, Clinical Center of Serbia, 2 Pasterova Street, 110000 Belgrade, Serbia.
: All subjects have signed an Informed Consent Form in relation to their participation in the CE-mark clinical investigation RXI 001 of RefluxStop™, which provides consent for the publication of anonymized data.
: PF is the inventor of the RefluxStop™ device, a specialist surgeon with focus on upper gastrointestinal surgery such as obesity and anti-reflux surgery. PF has been working for Implantica, the manufacturer of RefluxStop™ and the funder of the study. The other five authors (LH, MB, ZK and AA) declare that they have no competing interests.